RxSight Light Adjustable Lens (RxLAL) 60005-3215Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00818806020708), received between Jul 18, 2022 and Aug 11, 2026 — classified as 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A site reported to RxSight that a bilaterally implanted patient's Light Adjustable Lens was explanted from the right eye due to a shift in refraction and monocular diplopia after completion of light treatments. A new LAL was implanted as a replacement. Postoperatively, the site reported that the patient was satisfied with the results of the lens exchange and that the diplopia in the right eye was resolved.

  Patient problems: Diplopia/Double Vision; Visual Impairment

  MAUDE report 50212624 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS EXPLANTED FROM THE RIGHT EYE PRIOR TO COMPLETION OF LIGHT TREATMENTS DUE TO A DECREASE IN VISION AND VISUAL DISTURBANCE AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24794809 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS EXPLANTED DUE TO MISSED TARGET. IT WAS REPORTED THAT THE PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: Blurred Vision; Unspecified Eye / Vision Problem

  MAUDE report 24656240 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS EXPLANTED AFTER FINAL LOCK IN DUE TO "AIM ISSUES AND LACK OF CLARITY WITH GLASSES". A NEW LAL (SN (B)(6), +20.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 24069944 ↗
• InjuryJan 14, 2026Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A POSTERIOR CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) IN THE CAPSULAR BAG ON (B)(6) 2025. THE SURGEON ELECTED TO LEAVE THE LENS IN THE CAPSULAR BAG. DURING A POSTOPERATIVE EXAMINATION ON (B)(6) 2025, THE LENS WAS OBSERVED TO BE DISLOCATED. ON (B)(6) 2025, A SECONDARY PROCEDURE WAS ATTEMPTED TO REPOSITION THE LENS INTO THE CILIARY SULCUS. DURING THE PROCEDURE TO REPOSITION THE LENS, THE HAPTIC BROKE. THE LENS WAS EXPLANTED, A VITRECTOMY WAS PERFORMED, AND ANOTHER LAL (SN (B)(6), +22.5D) WAS IMPLANTED IN THE SULCUS AS A REPLACEMENT. DURING A POSTOPERATIVE EXAM, THE TREATING PHYSICIAN NOTED THAT THE PATIENT'S INTRAOCULAR PRESSURE WAS ELEVATED AND THE LAL HAD DISLOCATED AGAIN. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR THE YAMANE PROCEDURE TO REPOSITION THE LENS.

  Patient problems: Capsular Bag Tear; Unspecified Eye / Vision Problem

  MAUDE report 24067261 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED DUE TO THE PATIENT'S REPORT OF PERIPHERAL VISION LOSS AFTER LOCK IN. PER THE ATTENDING PHYSICIAN, THE PATIENT'S VISUAL FIELD WAS NORMAL.

  Patient problems: Visual Impairment

  MAUDE report 23649830 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +21.50D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 23609000 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 23074606 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D). AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE LENS WAS PLACED IN THE SULCUS.

  Patient problems: Capsular Bag Tear

  MAUDE report 22592641 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +21.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THEIR CHOSEN REFRACTIVE TARGET.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 22538609 ↗
• InjuryJun 26, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS (LAL, (B)(6), +21.5) ON (B)(6) 2024. NO LIGHT ADJUSTMENTS WERE PERFORMED, AND LOCK-IN TREATMENTS WERE COMPLETED ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT RETURNED TO CLINIC WITH COMPLAINTS OF HALOS AND STARBURSTS. ON (B)(6) 2025, THE LENS WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 22342667 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D). THE LAL WAS PLACED IN THE SULCUS AND AN ANTERIOR VITRECTOMY PERFORMED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22342661 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +21.5D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22342657 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS EXPLANTED DUE TO BLURRY VISION AND A NEW LAL (SN (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21401916 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS EXPLANTED DUE TO BLURRY VISION. A NEW LAL (SN (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21356903 ↗
• InjuryNov 27, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) WAS IMPLANTED (B)(6) 2024. POSTOPERATIVELY, THE LENS DISLOCATED AND WAS REPLACED WITH ANOTHER LAL (SN (B)(6), +21.5D) ON (B)(6) 2024. THE EXPLANTING SURGEON REPORTED THAT THE LENS HAPTIC APPEARED TO BE DISINSERTED FROM THE LENS PRIOR TO THE EXPLANTATION PROCEDURE AND THE HAPTIC WAS NOT FOUND DURING THE EXPLANT PROCEDURE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20791929 ↗
• InjurySep 13, 2024Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) IMPLANTED IN THE RIGHT EYE ON (B)(6) 2022. THE FIRST LIGHT TREATMENT WAS COMPLETED ON (B)(6) 2023, WITH NO FURTHER PRESCRIBED LIGHT TREATMENTS OR LOCK-INS PERFORMED, AND THE PATIENT RETURNED TO CLINIC ON (B)(6) 2024, COMPLAINING OF HALOS, GLARE, AND RINGS IN VISION. UPON SLIT LAMP EXAMINATION, THE TREATING PHYSICIAN NOTED A "RAISED" AREA WITHIN THE IMPLANTED LAL CONSISTENT WITH ZONE FORMATION. ON (B)(6) 2024, THE LAL WAS EXPLANTED, AND A NEW LAL WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/15/2024.

  Patient problems: Visual Disturbances

  MAUDE report 20216832 ↗
• MalfunctionSep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RXSIGHT WAS INFORMED A LIGHT ADJUSTABLE LENS (LAL, (B)(6)) WAS EXPLANTED DUE TO BEING IMPLANTED BACKWARDS DURING PRIMARY CATARACT SURGERY. ANOTHER LAL WAS IMPLANTED AS REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 9/4/2024.

  Patient problems: Visual Impairment

  MAUDE report 20163968 ↗
• InjuryAug 23, 2024Use of Device Problem; Use of Device Problem

  A PATIENT'S LIGHT ADJUSTABLE LENS LAL, SN (B)(6) WAS IMPLANTED ON (B)(6) 2022. THE PATIENT COMPLETED 2 LIGHT ADJUSTMENT TREATMENTS DURING THE POSTOPERATIVE PERIOD; THE PATIENT DID NOT COMPLETE THE REQUIRED LOCK-IN TREATMENTS. ON (B)(6) 2024, APPROXIMATELY 1 YEAR AND 8 MONTHS AFTER THE IMPLANT SURGERY, THE LAL WAS EXPLANTED AND AN INTRAOCULAR LENS FROM A DIFFERENT MANUFACTURER IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 07/26/2024.

  Patient problems: Visual Impairment

  MAUDE report 20057002 ↗
• InjuryJul 5, 2024Optical Decentration; Optical Decentration

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5) WAS EXPLANTED, AND A NEW LAL (SN (B)(6), +22.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/11/2024.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 19680836 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +21.5D) EXPLANTED FROM THE LEFT EYE (OS) DUE TO UNINTENDED VISUAL CHANGES AFTER USING A TANNING BED ON (B)(6) 2024, BEFORE ANY LIGHT TREATMENTS WERE COMPLETED. THE PATIENT DID NOT WEAR RXSIGHT UV PROTECTIVE SPECTACLES DURING TANNING BED USE. A NEW LAL (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 04/19/2024.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19346900 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT WHILE IMPLANTING THE LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +21.5D) DURING CATARACT SURGERY, A POSTERIOR CAPSULE TEAR OCCURRED. THE OPTIC WAS KEPT IN THE CAPSULAR BAG AND THE HAPTICS IN THE SULCUS. THERE WERE NO OTHER COMPLICATIONS OR PROBLEMS ASSOCIATED WITH THE SURGERY REPORTED TO RXSIGHT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 01/02/2024.

  Patient problems: Capsular Bag Tear

  MAUDE report 18602686 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN (B)(6), +21.5D) WAS EXPLANTED ON (B)(6) 2023. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17322377 ↗
• InjuryJun 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN(B)(6)), +21.5D) WAS EXPLANTED ON (B)(6) 2023 AND WAS REPLACED WITH A +19.0D LAL (SN (B)(6)). RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 17192253 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL SN (B)(6)) WAS EXPLANTED ON (B)(6) 2023. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17046898 ↗